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What the editorial is about?
The COVID-19 vaccination and booster doses strategy.
Recently, the Indian government announced ‘precaution shots’ or the ‘third dose’ of COVID-19 vaccines for select populations.
Major Developments Post Announcements of these ‘Precaution Shots’
There have been four relevant developments.
- First, two COVID-19 vaccines () have received ‘conditional market authorization’.
- Second, phase three clinical trials which include the booster dose of a nasal COVID-19 candidate vaccine have been approved.
- Third, the Omicron wave has largely swept through the country.
- Fourth, ₹5,000 crores have been allocated for COVID-19 vaccines in the Union Budget 2022-23.
Questions that Arise
- What do these new developments mean for the COVID-19 vaccination and booster dose strategy in India?
- Do healthy adults need a booster and when?
- Is the budgetary allocation for COVID-19 vaccines enough?
Conditional Market Authorization
- ‘Market Authorization’ usually means that anyone who wishes to, can buy a COVID-19 vaccine and have it administered at their will or on a doctor’s prescription as in the case of most medical products.
- However, these two COVID-19 vaccines have received not the full but a ‘conditional’ market authorization. Therefore, for the general public, nothing has changed.
- The Government will continue to regulate vaccine administration as earlier. The already eligible target groups (as per national guidelines), would continue to receive vaccines through authorized COVID-19 vaccination centres.
- The only effective change is for the vaccine manufacturers. From submitting safety and efficacy data to the national drug regulator every fortnight, they can now submit this data every six months.
- From submitting safety and efficacy data to the national drug regulator every fortnight, they can now submit this data every six months.
The Nasal Vaccine
Even though in the clinical trial stage, and none have been authorized yet, nasal COVID-19 vaccines have always garnered a lot of interest for a variety of reasons.
- One, the ease of administration without a needle and syringe (and thus less biomedical waste).
- Two, given that COVID-19 vaccines currently in use in India have limited evidence about their role in reducing transmission, nasal vaccines, through mucosal antibodies, are likely to perform better in reducing transmission.
- Three, nasal vaccines might be useful for children, in whom the primary objective of COVID-19 vaccination is in reducing transmission rather than the individual benefit.
- Four, the world needs more vaccines to ensure wider availability and address vaccine inequity.
- Five, combination use of injectable and nasal vaccines might provide blended protection from severe disease and reduce the transmission. Such an approach could be useful in mitigating the impact of the ongoing COVID-19 pandemic as well as in the control of outbreaks in the post-pandemic period.
However, a flip side of nasal vaccines and mucosal immunity is that protection is usually short lasting.
The Hybrid and Sandwich Immunity
- Epidemiological data and modelling estimates suggest that by the time the Omicron wave ends in any setting, 50% to 70% of the population could have been exposed.
- A study from South Africa found that the Omicron exposure in an individual with past infection or vaccination results in a 14-fold increase in antibodies, which offers protection from future Delta variant infection.
- The role of hybrid immunity acquired after natural infection in combination with two shots of COVID-19 vaccines provides better protection than vaccines alone.
- As an Omicron wave is sweeping through India, the country is at a stage that can be termed ‘sandwich immunity’ — hybrid immunity supplemented by another layer of natural infection.
Why no reason for any urgency to administer the COVID-19 booster except for a select population?
- In the backdrop of the hybrid and sandwich immunity, there is no reason for any urgency to administer COVID-19 booster doses to healthy adults in the age group 18 years-60 years.
- Similarly, children being at low risk of severe disease and having developed infections, and with further exposure of children in the ongoing Omicron surge, the vaccination of children younger than 15 years is also not an urgency, either.
What does this mean then?
- This does not mean that no population sub-group in the 18-59 years band would ever need COVID-19 vaccine boosters.
- One, immunity, and thus protection against respiratory viruses (i.e., SARS-CoV-2), whether after vaccination or natural infection, decline over some time.
- Two, mutations are common in SARS-CoV-2 and the emergence of newer variants of concern with an ability to bypass immunity (provided by natural infection or vaccination) continues to remain a possibility.
- Therefore, it is likely that a larger proportion of the adult population might need a booster, though at a relatively long interval.
- Furthermore, once there is evidence about the effectiveness of additional doses of COVID-19 vaccines (being used in India) in immunocompromised individuals, the third dose should be recommended for such adults, of any age group.
Funding of COVID-19 Vaccines
- Funding of COVID-19 vaccines is a key operational issue.
- Soon after the Union Budget 2022-23, there were concerns that the allocation of ₹5,000 crores for COVID-19 vaccines could be insufficient. However, an objective assessment suggests that it could be enough.
- The Indian government, last year, had reportedly made an advance market commitment (AMC) with the manufacturers of Corbevax (Biological E Ltd.) for 30 crore shots and had made part-payment of ₹1,500 crores in advance. Therefore, the advance payment would be enough for 10 crore doses.
- The budgetary allocation for the next financial year could be sufficient to procure 20 crores to 33 crore doses, depending on the share of different COVID-19 vaccines ordered.
- In addition, there is likely to be a balance of stocks of COVID-19 vaccines already purchased in the current financial year. These doses are likely to be sufficient to vaccinate the remaining eligible population and administer boosters to (currently and in future) eligible population sub-groups.
Use the time at hand
- In a pandemic response, efforts are made to reduce and halt any transmission. However, a fresh wave has a silver lining as well.
- Any natural infection results in the development of immunity. Therefore, the ongoing third wave gives India some time to decide about rolling out boosters for additional population sub-groups.
- This time at hand should be used for some reflection and actions.
Context or local Situation
- In the pandemic, epidemics, outbreaks and epidemiology, context or the local situation matters a lot.
- The context of India is very different from that in other countries because of the relatively low median population age, the use of different COVID-19 vaccines, and the vaccination of the majority of the population after natural infection in the second wave, to list a few.
- Therefore, the data used by the other countries in deciding on vaccine effectiveness and boosters cannot, and should not, be used for India.
- Such decisions need to be based on local data and evidence.
- The success of any vaccination program is dependent on citizen participation.
- It is time science determines the COVID-19 vaccination strategy.
- Let us, as citizens, not demand a booster for any adult age group. Let us not rush into the vaccination of children younger than 15 years of age.
- Let us not link vaccination to school attendance. Children need not be vaccinated to attend school.
- The unscientific and misinformed public discourse has been an ongoing challenge in India’s COVID-19 pandemic response.
- Therefore, governments at all levels need to step up transparent and timely science communication around vaccines and through trustworthy sources.
Vaccine and Vaccination-Specific Policy Questions
- There is a need to identify vaccine and vaccination-specific policy questions. Thereafter, analyze the COVID-19 disease and vaccine data and link them with clinical outcomes to assess the effectiveness against SARS-CoV-2 variants and answer as many policy questions as possible.
- This needs to be supplemented by conducting primary research, both clinical and epidemiological, for the policy questions that have not been answered by the available data.
- India’s COVID-19 vaccination drive has matured with commendable coverage: approximately 95% of eligible adults with one shot and 75% of eligible adults with both shots. However, the task is still unfinished.
- The sufficient COVID-19 vaccine supply or high vaccine coverage in adults is not reason enough to open booster doses for additional age groups.
- The COVID-19 vaccination and booster doses strategy should be determined by keeping context in the backdrop and being solely informed by emerging scientific and epidemiological evidence.
- Alongside, rather than being solely focused on COVID-19 vaccines and boosters — in the weeks and months — we, as a society, need to come to a consensus and prepare a road map to ‘live with SARS-CoV-2’.